In 2002, the U.S. Food and Drug Administration (FDA) approved a product called Medtronic Infuse. This medical device consists of a genetically engineered protein used to help regrow bone in the spine. While this sounds ideal in theory, Attorney Gary Falkowitz explains, reports indicate that Infuse is dangerous and can lead to a number of serious side effects. Even more disconcerting, a Senate investigation recently revealed that Medtronic has taken several measures to hide the side effects linked to Infuse. According to a report by the United States Senate Finance Committee, Medtronic has paid researchers $210 million over the course of 15 years and these financial ties were never disclosed. To make matters worse, the investigation also found that Medtronic edited several medical journals about Infuse.
Medtronic has been having a number of legal issues regard the safety of Infuse, mainly concerning its off-label use. “Off-label” refers to the use of a drug or medical device in any manner not approved by the FDA. Infuse is approved for surgeries in the lower lumbar regions of the spine performed through the front of the body. However, about 85 percent of Infuse procedures are off-label, which may include use in the cervical spine, without a cage, being performed through the back, etc. Complications associated with Infuse include retrograde ejaculation and male sterility, excess bone growth, nerve damage, difficulty breathing or swallowing (particularly when used in the cervical spine) and possibly cancer.